Glipizide and Metformin Hydrochloride (Page 4 of 10)
Patients with Inadequate Glycemic Control on Sulfonylurea Monotherapy:
In an 18-week, double-blind, active-controlled U.S. clinical trial, a total of 247 patients with type 2 diabetes not adequately controlled (HbA 1c ≥ 7.5% and ≤ 12% and FPG < 300 mg/dL) while being treated with at least one-half the maximum labeled dose of a sulfonylurea (e.g., glyburide 10 mg, glipizide 20 mg) were randomized to receive glipizide (fixed dose, 30 mg), metformin (500 mg), or glipizide and metformin hydrochloride tablets 5 mg/500 mg. The doses of metformin and glipizide and metformin hydrochloride tablets were titrated (up to the eight-week visit) to a maximum of four tablets daily as needed to achieve MDG ≤ 130 mg/dL. Trial data at 18 weeks are summarized in Table 3.
| Glipizide Tablets 5 mg | Metformin Tablets 500 mg | Glipizide and Metformin Hydrochloride Tablets 5 mg / 500 mg | |
| |||
| Mean Final Dose | 30.0 mg | 1927 mg | 17.5 mg/1747 mg |
| Hemoglobin A 1 c (%) | N = 79 | N = 71 | N = 80 |
| Baseline Mean | 8.87 | 8.61 | 8.66 |
| Final Adjusted Mean | 8.45 | 8.36 | 7.39 |
| Different from Glipizide | -1.06 * | ||
| Different from Metformin | -0.98 * | ||
| % Patients with Final HbA 1 c <7% | 8.9% | 9.9% | 36.3% |
| Fasting Plasma Glucose ( mg / dL ) | N = 82 | N = 75 | N = 81 |
| Baseline Mean | 203.6 | 191.3 | 194.3 |
| Adjusted Mean Change from Baseline | 7.0 | 6.7 | -30.4 |
| Difference from Glipizide | -37.4 | ||
| Different from Metformin | -37.2 | ||
After 18 weeks, treatment with glipizide and metformin hydrochloride tablets at doses up to 20 mg/2000 mg per day resulted in significantly lower mean final HbA 1c and significantly greater mean reductions in FPG compared to glipizide and to metformin therapy. Treatment with glipizide and metformin hydrochloride tablets lowered the three-hour postprandial glucose AUC, compared to baseline, to a significantly greater extent than did the glipizide and the metformin therapies. Glipizide and metformin hydrochloride tablets did not significantly affect fasting insulin levels.
There were no clinically meaningful differences in changes from baseline for all lipid parameters between glipizide and metformin hydrochloride tablets therapy and either metformin therapy or glipizide therapy. The adjusted mean changes from baseline in body weight were: glipizide and metformin hydrochloride tablets 5 mg/500 mg, -0.3 kg; glipizide, -0.4 kg; and metformin, -2.7 kg. Weight loss was greater with metformin than with glipizide and metformin hydrochloride tablets.
INDICATIONS AND USAGE
Glipizide and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
CONTRAINDICATIONS
Glipizide and metformin hydrochloride tablets are contraindicated in patients with:
- Severe renal impairment (eGFR below 30 mlL/min/1.73 m 2)
- Known hypersensitivity to glipizide or metformin hydrochloride.
- Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin.
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